Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorWeill Medical College of Cornell University
About this trial
The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.
Eligibility criteria
Qualifiers
Age >18 years
Documented histological or cytological diagnosis of PC
Evidence of metastatic PC on imaging (bone scan and/or CT/MRI scan)
Diagnosis of progressive metastatic, castration resistant prostate cancer
Disqualifiers
Receipt of any type of biologic, or other systemic anticancer therapy (including investigational) except agents within 4 weeks before first dose of study treatment. Anti-resorptive bone agents are also allowed.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Prior exposure to taxane chemotherapy
History of pneumonitis
Trial design
Treatments tested in this trial
- TVB-2640
- Enzalutamide
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Sagimet Biosciences Inc.
Collaborator
Source ClinicalTrials.gov